Some degree of drug waste at your facility is inevitable, but it is worth the effort to try to reduce drug waste as much as possible.

The drawbacks of drug waste include: cost of over-purchasing, expired, unusable drugs, unused drugs at the site level, and the environmental impact of destroying unused drugs. However, eliminating drug waste is a challenge. There is unpredictability in the demand for a drug, making it hard to set aside the right amount. Some overage in stock is even required to be successful; you need to make sure that there is stock on site in case of damage or lost drugs, or unexpected demand.

But there are ways to reduce drug waste. Start thinking about your drug stock early in the protocol design stage of your study. Supply is often tacked on at the end of the planning process, often leading to oversupply, which in turn leads to wastage. When planning, imagine the worst case scenario of your need for the drug, and work back from that. Consider the likelihood of each need for an increased supply, and weight it accordingly in your planning.

Once you’re in the midst of a study, we suggest implementing drug pooling across protocols. If you have three or four studies open, rather than assigning separate supplies to each site, your supply can be retargeted to another protocol that’s using the same drug. We also recommend on-demand service, meaning that instead of pre-packaging drugs, you only package what is needed for a patient in the next week, as opposed to planning for an entire trial. This would not be recommended for large multinational trials. During the planning process, you could also take kit size into account to better align with patient visits. For example, when you enroll patients now, and they’re going to be in therapy for six months, you might put all six bottles in one kit. However, if the patient doesn’t tolerate the first bottle, or drops out, you have wasted five bottles. Instead, consider bottle assignment. The patient get the first bottle when they first come in, the second at the next appointment, and so on. In this way we reduce the cost of waste.

It is also important to amend your planning process as drug technology changes. With emerging BioTechs, we’re seeing an increase of vials of injectables, each worth thousands of dollars. You may need to manually monitor and manage expiration dates at sites and depots, because sponsors don’t realize that the drugs have a short life, and that you will have to plan for much shorter production times. You will also need to be careful with repackaging needs, since you have less control over dosages. For example, the drug may come in a 200mg vial, but the dose is 120mg, meaning you waste 80mg. The packager may be able to suggest alternate vial weights, giving you a wider variety of options to avoid that waste.

A better dosing strategy will also save money and reduce drug waste. Ideally, you want to discuss this strategy at the protocol development stage, as opposed to the logistics stage, since many potential issues come up when you try to get the drug in and figure out how much you need at a later planning stage.

Also consider appropriate transport and storage. Some companies and sponsors prefer using specific shippers with monitoring devices to ensure the temperature is controlled, which is fine for highly sensitive drugs but may not be required for others, and which will incur an extra cost.

Remember, there are times where you may have to accept overages in stock: to account for patients losing their supply, for changes in studies’ needs, for expired drugs if enrollment is slow, or if the packaging company wastes the drug during the bottling process. But wherever possible, we suggest implementing measures to reduce drug waste for the sake of efficiency and expense.

 

 

 

 

 

 

Bay Area Research Logisitics

Author Bay Area Research Logisitics

More posts by Bay Area Research Logisitics

Leave a Reply